Pharmacovigilance

ANUSHA PARMESHWAR

A GE: **

MSc in Drug Delivery, University College London, U K (2012)

BPharm, Dr BNCP, Mumbai University, Mumbai (2011)

Address: No 10 Jalan, Setia Perdana U 13/ 26E, Precint 12, Setia alam, 40170 Shah Alam, Selangor

M: +60-122****** E: *************@*****.**.**

Profile

• Highly Motivated individual with a passion to succeed

• Abili ty to work independently as well as in team under t ight schedule and excellent

t ime management skills

• Strong planning and organizing skills

• Abili ty to work in cross-functional team

Career Objective

• To make a sound position in corporate world and work enthusiastically in team to

achieve goal of the organization with devotion and hard work.

• To seek challenging assignment and responsibility, with an opportunity for growth

and career advancement as successful achievements.

• To be an astute learner and the best performer in your organization. So that I can

build an innovative career in your esteemed organization by using my skills and

other significant talents

Employment

Company Department Position held Timeline

Novartis India Drug Safety & Trainee 03 May 2013 – 28

L imited E pidemiology / Feb 2014

Pharmaceuticals Pharmacovigilance

D ivision Operations

Work Experience

NOVART IS I N D IA L I M I TE D- P HARMACEUT ICAL D IV IS ION

Position: Trainee – DS&E

Responsibilities

• Managed collection, processing, documentation, reporting and follow-up of all

serious adverse events (SAE) report for all Novartis products from clinical t r ials, and all

adverse events from Patient Oriented Programs, post-marketing studies (PMS), registries

and all Spontaneous Reports (SR)

• Transcribed, t ranslated and entered data of all Serious Adverse Events (from

C linical Trials) and all adverse events (from Patient Oriented Programs, PMS,

registries and all SRs) from source documents onto safety systems (Argus Affiliate

A A7) accurately and consistently with emphasis on timelines and quality.

• Participated in the verification process of data correctness in the global safety

databases

• Managed submission of safety reports (e.g. SAEs, SR) to Local Health authorities

• Determined the necessity for follow up, prepare, and perform follow up as required.

• Interacted and exchanged relevant safety information with Local Health authority,

PVO associates, other functional groups and third party contractor

• Performed reconciliation with other departments (Medical Information, Quality

Assurance) for potential AEs resulting from medical inqui ries and quality related

complaints

• Developed and updated t raining materials for pharmacovigilance and ensure

t raining of CPO associates on relevant PVO procedures for AE reporting, including field

force and third party.

• Supported for and close- out of audits, corrective action plan, investigation and

Health authority inspections.

• Ini tiated discussion within the team for Product Guidance Documents (PGDs) and

i dentification of potential Lack of Efficacy cases

• Designing ‘Adverse Event Reporting of Novartis Drug’ t raining and ensuring i ts

u ploading in the local iLearn module portal.

Academia

Masters in D rug Delivery – Awarded with Distinction-University College London, U K

2011 –2012

• Pediatric drug delivery, Preformulation studies, Methods of Analysis,

Modes of Drug Delivery, Hospital Management & Production and a six

months thesis project

Bachelors in Pha rmacy – Awarded with First class- Dr Bhanuben Nanavati College of

Pharmacy, Mumbai University, India 2007-2011

Computer Skills

• Argus Affiliate (AA7)

• M icrosoft Office

• Windows & Macintosh Operating Systems

L anguage Proficiency

E nglish, Hindi, Tamil, Marathi, Malayalam

Contact this candidate